Name: Medrolgyn (ketorolac) solution for injections 30 mg/ml. №5
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medrolgyn-solution-for-injections-30-mg-ml-n5

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This drug Medrolgyn for the relief of moderate and severe postoperative acute pain for a short time.
Treatment should be started only in hospitals. The maximum duration of treatment is 2 days.

Category: Anesthetic

Description

Description

Medrolgyn composition
active substance: ketorolac;
1 ml of solution contains ketorolac trometamol 30 mg;
Excipients: disodium edetate, ethanol 96%, sodium chloride, sodium hydroxide, water for injections.

Dosage form
Solution for injection.

Pharmacological properties
Medrolgyn is a potent non-steroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity. It is not an opioid and has no effects on opioid receptors. The mechanism of action of ketorolac is to inhibit the cyclooxygenase enzyme system, thus it inhibits the synthesis of prostaglandins. When using an analgesic dose demonstrates minimal anti-inflammatory effect.

Indication
This drug Medrolgyn for the relief of moderate and severe postoperative acute pain for a short time.
Treatment should be started only in hospitals. The maximum duration of treatment is 2 days.

Contraindication:

Hypersensitivity to ketorolac, other NSAIDs or to other excipients.
Allergic reactions to acetylsalicylic acid or other prostaglandin synthesis inhibitors (severe anaphylactic reactions have been reported in such patients) with asthma, rhinitis, angioneurotic edema or urticaria.
History of bronchial asthma.
Active peptic ulcer, recent gastrointestinal bleeding or perforation, peptic ulcer disease, history of gastrointestinal bleeding or perforation.
Severe heart failure, liver failure and renal failure.
Moderate or severe renal impairment (plasma plasma creatinine> 160 μmol / l).
Hypovolemia, dehydration with a risk of renal failure due to decreased fluid volume.
Contraindicated prophylactic use before surgery (due to inhibition of platelet function) and use during surgery due to increased risk of bleeding.
Do not use in patients who have had surgery at high risk of hemorrhage or incomplete cessation of bleeding.
Suspected or confirmed cerebrovascular bleeding, high risk of bleeding, such as hemorrhagic diathesis, including coagulation disorders (due to platelet suppression).
Concomitant use with anticoagulants, including warfarin and low doses of heparin (2500-5000 units every 12 hours).
Concomitant use with acetylsalicylic acid or other NSAIDs (including selective cyclooxygenase-2 inhibitors).
Neuroaxial (epidural or intrathecal) administration is contraindicated because the drug contains ethyl alcohol.
Concomitant use with pentoxifylline.
Concomitant use with probenecid or lithium salts.
Complete or partial nasal polyp syndrome, angioneurotic edema or bronchospasm.

Children
The safety and efficacy of ketorolac have not been established. The drug is contraindicated in children under 16 years of age.

Use during pregnancy or breastfeeding
The drug Medrolgyn is contraindicated during pregnancy or breastfeeding.

Method of application and dosage
The drug Medrolgyn is intended for intramuscular or bolus intravenous administration.
Bolus intravenous administration should last at least 15 seconds.
The drug should not be used for epidural or spinal administration.
After intramuscular or intravenous administration, the analgesic effect is observed after about 30 minutes, and the maximum analgesia occurs after 1-2 hours. In general, the average duration of analgesia is 4-6 hours. The dose should be adjusted according to the severity of the pain and the patient’s response to treatment.
The recommended initial dose of ketorolac is 10 mg, followed by 10-30 mg every 4-6 hours (if necessary). In the initial postoperative period, ketorolac can be administered every 2 hours if necessary.
The minimum effective dose should be used. The total daily dose should not exceed 90 mg for young patients, 60 mg for elderly patients, patients with renal insufficiency and patients weighing less than 50 kg. The maximum duration of treatment should not exceed 2 days.
For patients weighing less than 50 kg, the dose should be reduced.

Overdose
Symptoms.
A single overdose of ketorolac led to abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and / or erosive gastritis, renal dysfunction that occurred after cessation of ketorolac.
Gastrointestinal bleeding may occur.
Hypertension, acute renal failure, respiratory depression and coma may occur after NSAID administration, although such symptoms are rare.
In addition, headache, epigastric pain, disorientation, agitation, drowsiness, dizziness, tinnitus and fainting, as well as rare cases of diarrhea or isolated seizures are possible.
Anaphylactoid reactions have been reported with therapeutic doses of NSAIDs, which may also occur in case of overdose.
Treatment.
In case of overdose, symptomatic and supportive therapy should be given. There is no special antidote. Dialysis does not significantly remove ketorolac from the blood due to its high protein binding.
Appropriate diuresis should be provided. Liver and kidney function should also be monitored, and the patient should be monitored for at least 4 hours after administration of a toxic amount of ketorolac. Diazepam should be used in case of recurrent or prolonged seizures. Other therapeutic measures may also be required depending on the patient’s clinical condition.

Side effects:

Infections and infestations: aseptic meningitis (especially in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease with the following symptoms: fever, severe headache, convulsions, neck and / or back muscle rigidity, nausea, vomiting, disorientation).
From the blood and lymphatic system: aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, neutropenia, purpura.
From the immune system: hypersensitivity reactions, including anaphylaxis (may be fatal) or anaphylactoid reactions (skin discoloration, skin rash, urticaria, itchy skin, tachypnea or dyspnea, eyelid edema, periorbital edema, dyspnea, difficulty breathing, heaviness in the chest, wheezing), angioneurotic edema.
From the metabolism and nutrition: anorexia, hyperkalemia, hyponatremia.
From the nervous system: drowsiness, impaired concentration, euphoria, headache, dizziness, anxiety, asthenic syndrome, paresthesia, insomnia, malaise, fatigue, agitation, unusual dreams, confusion, hyperkinesia; hyperactivity (mood swings, anxiety), hallucinations, depression, psychosis, unconsciousness; pathological thinking, taste changes, psychotic reactions, nervousness, irritability, disorientation, convulsions.
On the part of the visual organs: visual disturbances, visual perception, optic neuritis.
From the hearing organs: ringing in the ears, hearing loss, hearing loss, vertigo.
From the kidneys and urinary system: hemolytic-uremic syndrome (hemolytic anemia, renal failure, thrombocytopenia, purpura), acute renal failure, nephrotoxicity, including increased urination, oliguria, pain in the side (with / without hematuria) , urinary retention, nephrotic syndrome, dysuria, papillary necrosis, low back pain, hematuria, azotemia.
From the cardiovascular system: pallor, palpitations, palpitations, chest pain, bradycardia, hot flashes, hypotension.
From the digestive tract: most often gastrointestinal side effects occur. Possible erosive-ulcerative lesions of the gastrointestinal tract, perforation of the ulcer, bleeding (hematemesis, melena), sometimes fatal (especially in the elderly) (see section “Features”), nausea, vomiting, dyspepsia, abdominal discomfort, abdominal epigastric pain, spasm or burning, diarrhea, dry mouth, thirst, flatulence, constipation, acute pancreatitis, bloating, esophagitis, belching, exacerbation of colitis and Crohn’s disease, ulcerative stomatitis, gastritis.
From the reproductive system and mammary glands: female infertility
From the respiratory system, chest and mediastinum: bronchial asthma, exacerbation of bronchial asthma, pulmonary edema; bronchospasm, dyspnea, laryngeal edema.
From the hepatobiliary system: hepatitis, cholestatic jaundice, liver failure, hepatomegaly.
Skin and subcutaneous tissue disorders: pruritus, purpura, exfoliative dermatitis (redness, thickening or peeling of the skin, enlargement and / or soreness of the tonsils), photosensitization, skin rash (including maculopapular), erythema multiforme, bullosa – Johnson, toxic epidermal necrolysis (Lyell’s syndrome).
From the hemostasis system: postoperative bleeding, nasal bleeding, rectal bleeding, subcutaneous hemorrhage, hematomas.
From the musculoskeletal and connective tissue: myalgia, functional disorders.
On the part of the body as a whole and reactions at the injection site: edema (face, shins, fingers, foot, tongue), reactions and pain at the injection site, fever (with or without chills), increased sweating, weight gain, sepsis.